Program Design and Process Setup

Successful Early Access Programs (EAPs) begin with a solid design and clearly defined processes. At MedWatch Consulting, we support sponsors in developing eligibility criteria, informed consent procedures, workflows, forms, and responsibilities that ensure programs are both patient-focused and compliant with global regulations.

We also assist in preparing SOPs and training for all stakeholders, and establish clear communication channels between physicians, sponsors, and regulatory authorities. By aligning program structure with FDA, EMA, and national requirements, we help organizations implement expanded access programs that are efficient, transparent, and inspection-ready.

With our guidance, you gain a reliable framework that supports timely patient access to treatment while safeguarding regulatory integrity and operational excellence.

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